Trial Master File: Guidance on preparing for an FDA inspection. Potential FDA registration studies that could be submitted to the FDA under a New Drug Application (NDA) include S1400, S1404, S1418 and S1605. All institutions participating in these studies must maintain a study-specific Trial Master File in order to be inspection ready.
Office for Human Research Protections: OHRP provides leadership in the protection of the rights, welfare, and well-being of subjects involved in research conducted or supported by the U.S. Department of Health and Human Services. OHRP helps ensure this by providing clarification and guidance, developing educational programs and materials, maintaining regulatory oversight and providing advice on ethical and regulatory issues in biomedical and social-behavioral research.
